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CompletedNCT00437762TBAUpdated May 14, 2026

Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment

A Phase 3 interventional study of Botulinum Toxin A Injection and Placebo injection in Tennis Elbow, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Some studies valued the effectiveness of botulinum toxin. Results are contradictory and we need more studies. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months. Method : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.

Read the detailed description
  • Principal Objective : The first aim of the study is to value the effectiveness of botulinum toxin injection in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months..
  • Secondary Objective : The second aim of this study is to document the tennis elbow history by a one year following after initial injection
  • Study design : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.
  • Inclusion criteria : tennis elbow during more than 6 months ; signature of consent
  • Exclusion criteria : Non inclusion criteria : less than 18 years old ; osteoarthritis elbow, referred cervical pain, fibromyalgia, pregnancy, myasthenia, polymyositis, SLA, anticoagulant treatment, aminosides ; diabetes, alcoholism
  • Study plan: randomized parallel groups
  • Number of subjects : 60
02

Conditions studied

  • Tennis Elbow

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Keywords

  • Lateral epicondylitis, tennis elbow, treatment
03

In context

Tennis Elbow

284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.

This study's enrollment of 61 is above the median of 50 across 253 interventional studies indexed under Tennis Elbow.

Browse Tennis Elbow studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Tennis elbow during more than 6 months
  • Signature of consent

Exclusion criteria

Exclusion Criteria:

  • Less than 18 years old
  • Osteoarthritis elbow
  • Referred cervical pain
  • Fibromyalgia
  • Pregnancy
  • Myasthenia
  • Polymyositis
  • SLA
  • Anticoagulant treatment
  • Aminosides
  • Diabetes
  • Alcoholism
  • Previous botulinum toxin A injections
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    1

    Botulinum Toxin A Injection

    Drug: Botulinum Toxin A Injection

  • Placebo comparator
    2

    Placebo injection

    Drug: Placebo injection

Interventions

  • DrugBotulinum Toxin A Injection

    Botulinum Toxin A Injection

  • DrugPlacebo injection

    Placebo Injection

06

What researchers measure

Primary outcomes

  1. Principal criteria of assessment is pain intensity three months after injection.

    Time frame: at 3 month

Secondary outcomes

  1. pain intensity

    Time frame: to day 30, 90,180, 365

  2. Number of painful days

    Time frame: to day 30, 90,180, 365

  3. Number of associated treatments.

    Time frame: to day 30, 90,180, 365

  4. Free pain grip strength

    Time frame: to day 30, 90,180, 365

  5. Rate of recidivism after initial relief

    Time frame: to day 30, 90,180, 365

07

Study locations

1 site
  • Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.
    Bordeaux, 330076, France
08

References and documents

Publications

  • Cogne M, Petit H, Creuze A, Liguoro D, de Seze M. Are paraspinous intramuscular injections of botulinum toxin a (BoNT-A) efficient in the treatment of chronic low-back pain? A randomised, double-blinded crossover trial. BMC Musculoskelet Disord. 2017 Nov 15;18(1):454. doi: 10.1186/s12891-017-1816-6. PubMed 29141611 ↗
  • Creuze A, Petit H, de Seze M. Short-Term Effect of Low-Dose, Electromyography-Guided Botulinum Toxin A Injection in the Treatment of Chronic Lateral Epicondylar Tendinopathy: A Randomized, Double-Blinded Study. J Bone Joint Surg Am. 2018 May 16;100(10):818-826. doi: 10.2106/JBJS.17.00777. PubMed 29762276 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00437762
Lead sponsor
University Hospital, Bordeaux
Collaborators
Ipsen
Responsible party
Sponsor
First posted
Feb 21, 2007
Start date
Apr 2007
Primary completion
Jun 2012
Completion
Jun 2012
Last update
May 14, 2026

Study contacts

Mathieu DE SEZE, MD
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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